Three‐year outcome of drug‐eluting stent implantation for coronary artery bifurcation lesions

Objectives: To compare the very long‐term clinical outcomes of bifurcation lesions using the crush and the simultaneous kissing stent (SKS) techniques. Background: A variety of two‐stent techniques have been used to treat coronary artery bifurcation lesions in the drug‐eluting stent era, but the long‐term clinical outcome of these approaches is not known. Methods: A total of 74 consecutive patients underwent bifurcation stenting using either the crush or SKS techniques. Mean patient age was 66.91 ± 11.3 years; 26% were diabetic, and the left anterior descending/diagonal bifurcation was the most frequently treated lesion (68%). Results: In‐hospital outcomes were not significantly different between groups. Over a median follow‐up of 3.3 years, 1 patient in the SKS group and 3 patients in the crush group died (P = ns). Probable stent thrombosis leading to death according to the Academic Research Consortium definition occurred in 1 patient in the crush group. Mortality in the remaining 3 patients was noncardiac. Target lesion revascularization (TLR) occurred in 14 patients (40%) in the SKS group and 5 patients (12.8%) in the crush group (P = 0.015). Survival free from major adverse cardiac events (MACE) was significantly less in the SKS group and predominantly driven by TLR (60 vs. 88%, P = 0.001). Conclusions: In conclusion, over a median of 3.3 years of follow‐up, TLR and MACE are significantly lower in bifurcation lesions treated with the crush technique when compared with the SKS technique. Definite or probable stent thrombosis is rare with either technique. © 2009 Wiley‐Liss, Inc.     

Sirolimus-eluting stents and calcified coronary lesions: clinical outcomes of patients treated with and without rotational atherectomy.

This study examined the outcomes of patients who underwent sirolimus-eluting stent (SES) implantation for the treatment of heavily calcified coronary lesions (HCCL) with and without the use of rotational atherectomy (rotablator). We investigated 150 consecutive patients with angiographic evidence of HCCL who underwent SES implantation. Sixty-nine patients underwent SES implantation without the need of rotablator (SES), and 81 patients required rotational atherectomy to modify the plaque and facilitate the delivery of the stent (SES + rotational atherectomy). Clinical success was equivalent in both groups (>98%) and there were no in-hospital outcome differences. At 6 months, the target lesion revascularization rate was 4.9% in SES vs. 4.2% in SES + rotational atherectomy groups, respectively (P = NS). Mortality at 6 months was 7.9% in the SES group vs. 6.8% in the SES + rotational atherectomy group (P = NS). SES performs well in patients with complex HCCL, with a relative low event rate. Lesions requiring rotational atherectomy to facilitate dilation and stenting had similar outcomes after SES implantation to those that could be stented without the need for rotablator.     

血管内超声指导对于冠状动脉真性分叉病变介入治疗长期预后的影响

目的研究血管内超声（intravascular ultrasound,IVUS）指导对于冠状动脉真性分叉病变植入药物洗脱支架（drug eluting stent,DES）长期预后的影响。方法通过分析2005年10月至2010年3月DK—Crush系列随机对照研究入选735例原位冠状动脉真性分叉病变植入DES患者,应用倾向评分匹配临床和造影特征,165例IVUS指导和165例冠状动脉造影指导患者纳入研究,比较两组患者的长期预后。结果两组临床基线资料和造影特征比较,差异无统计学意义（P〉0．05）。IVUS指导组更常见选择双支架策略（P=0．007）,IVUS指导组主支血管（MV）和分支血管（SB）的最大支架直径和支架总长度以及分支血管支架个数显著超过常规造影指导组;介入治疗后QCA分析显示,IVUS指导组分支血管参考血管直径（RVD）和即刻获得以及主支血管近端和分支血管最小管腔直径（MLD）显著超过造影指导组。12个月随访发现两组心脏死亡、靶病变重建（TLR）和主要心血管事件（MACE）比较,差异无统计学意义（P〉0．05）。然而,IVUS指导组晚期支架内血栓和急性心肌梗死发生率显著低于造影指导组,差异有统计学意义（0．6％ vs.4．8％。P=0．04;1．8％ vs.6．7％,P=0．03）。结论IVUS指导冠状动脉真性分叉病变植入DES可以显著减低晚期支架内血栓和由此引起急性sT段抬高心肌梗死发生率而改善长期预后。     

Polymer‐free drug‐eluting stents for coronary artery disease

Polymer‐free drug‐eluting stents (PF‐DES) were designed with the expectation of avoiding late restenosis and thrombosis related to the polymer used in traditional DES platforms. Furthermore, due to similarities with bare metal stents after drug elution, PF‐DES has been considered as particularly suitable for patients at high bleeding risk. A variety of PF‐DES platforms have been clinically tested. Despite their theoretical advantages, PF platforms showed comparable clinical outcomes with modern permanent‐ or biodegradable polymer‐based DES up to 5 years after implantation. Use of more biocompatible polymers on the modern DES platforms is one of the reasons therefore. Their improved safety profile allows already less intensive antithrombotic regimes after DES. Hence, nowadays PF‐DES platforms can be considered as one of many DES options for percutaneous treatment of coronary artery disease.

     

Therapeutic effect of rotational atherectomy with implantation of drug eluting stent in heavily coronary calcified patients

Background Rotational atherectomy (RA) could facilitate the percutaneous coronary intervention (PCI) in heavily coronary calcified patients. The effectiveness and safety of this technique needs to be further evaluated. Methods & Results Eighty patients who underwent RA in our center from September 2011 to June 2014 were enrolled. The mean age was 72.4 ± 10.4 years. The left ventricular ejection fraction (LVEF) was average 52.3% ± 8.48% and the estimated glomerular filtration rate was 73.2 ± 3.20 mL/min per 1.73 m². The coronary lesions were complex, with Syntax score 29.5 ± 9.86. The diameter of reference vessel was 3.4 ± 0.45 mm and the average diameter stenosis of target vessels was 80% ± 10%. All the patients were deployed with drug eluting stents (DES) successfully after RA. The patients were followed up for 12–18 months. Kaplan-Meier plots estimated the survival rate was 93.4% and the cumulative incidence of major adverse cardiac and cerebral events (MACCE) was 25.4%. Bleeding and procedural-related complications were quite low. COX proportional hazards model for multivariate analysis demonstrated that diabetes, LVEF and maximum pressure of postdilatation were the predictors of MACCE. Conclusions RA followed by implantation of DES was effective and safe for heavily coronary calcified patients. Diabetes, LVEF and maximum pressure of postdilatation were predictive for MACCE.     

冠状动脉旋磨术在冠心病钙化病变介入治疗中的应用

目的探讨冠状动脉旋磨术治疗冠状动脉钙化病变的安全性及有效性。方法回顾性分析12例行冠状动脉旋磨术结合冠状动脉球囊成形术和支架植入术的冠状动脉粥样硬化性心脏病(冠心病)患者的临床资料,着重分析手术方法、手术成功率、术后随访主要心血管事件(包括心源性死亡、心肌梗死、靶病变血运重建)的发生率。结果 12例患者共有16处钙化病变,有15处钙化病变行冠状动脉旋磨术,管腔狭窄由术前的87%±10%减少至42%±9%,结合冠状动脉球囊成形术,共植入18枚国产药物支架,手术成功率为93.75%(15/16)。1例因血管严重扭曲,球囊扩张后出现冠状动脉夹层,植入支架失败,建议行外科冠状动脉旁路移植术。术中均无主要并发症(包括心源性死亡、Q波心肌梗死、急诊冠状动脉旁路移植术)发生。所有患者随访(8.4±3.6)个月,有2例再发心绞痛,无主要心血管事件(包括心源性死亡、心肌梗死、靶病变血运重建)发生。5例患者复查冠状动脉造影,有1例出现支架内再狭窄30%。结论冠状动脉旋磨术联合球囊扩张和支架植入术治疗冠状动脉钙化病变可取得很高的手术成功率,是治疗钙化病变安全、有效的方法。     

Extended follow‐up safety and effectiveness of the Endeavor zotarolimus‐eluting stent in real‐world clinical practice: Two‐year follow‐up from the E‐Five Registry

Objectives: To present data from the cohort of patients in the all‐comers Endeavor zotarolimus‐eluting stent (ZES) registry (E‐Five) who underwent 2‐year follow‐up. Background: The Endeavor ZES has been shown to be safe and efficacious for treatment of single, de novo lesions in patients with stable coronary artery disease. E‐Five evaluated the ZES in over 8,000 real‐world patients, at 188 sites followed to 1 year. A subset of sites continued follow‐up through 2 years to evaluate late‐term safety and effectiveness of the ZES in this population with diverse clinical and lesion characteristics. Methods: E‐Five, a prospective, multicenter, nonrandomized global registry, collected 2‐year outcomes for 2,116 patients from 26 centers. Sites were selected for participation based on patient accrual rates and the ability to continue follow‐up activities for an additional year. Complete data was available for 2,054 patients. To observe whether or not a sustained benefit was achieved, data for all patients from the selected sites were included in the analysis. Results: The outcomes in the 2‐year cohort tracked with the results of randomized controlled trials using the Endeavor ZES. One year results were MACE 7.5%, TLR 4.5%, and ARC definite/probable stent thrombosis 0.6%. Outcomes at 2 years for MACE, TLR, and ARC definite/probable stent thrombosis were 8.5, 5.1, and 0.7%, respectively. Conclusions: Long‐term efficacy and safety outcomes were maintained between 1 and 2 years for the 2‐year patient cohort, with only a small number of additional MACE, TLR, and very late stent thrombosis events. © 2010 Wiley‐Liss, Inc.     

Short‐term and long‐term clinical outcomes of rotational atherectomy in resistant chronic total occlusion

Objectives

To evaluate the short‐ and long‐term clinical outcomes of RA in CTO coronary intervention.

Background

The application of rotational atherectomy (RA) may improve the success rate of percutaneous recanalization of chronic total occlusion (CTO) with heavy calcification.

Methods

From January 2011 to September 2014, we enrolled 285 patients with CTO who underwent successful percutaneous coronary intervention (PCI). Resistant CTO lesions were defined as those with heavy calcifications as well as those that no devices are able to pass after guide wire crossing.

Results

All patients with resistant CTO lesions (n = 26) were successfully treated by RA without major complications, except 1 patient complicated with coronary perforation and treated by surgery successfully (success rate: RA group vs non‐RA group: 96.2%, vs 89.5%, P = 0.038). Compared to the non‐RA group, the patients in the RA group were older (P = 0.028), had higher J‐CTO scores (P = 0.001), and needed longer stents (P = 0.001). All patients were followed up for a mean period of 3.4 ± 2.3 years, and the 1‐year and long‐term clinical outcomes of the RA group were excellent and comparable with those not receiving RA in multivariate analysis adjusted for multiple variables.

Conclusion

The treatment of RA is safe and feasible for resistant CTO lesions with heavy calcification. The short‐ and long‐term clinical outcomes of the treatment of RA were excellent and comparable with those not needing RA for CTO PCI.

     

Aneurysm formation after drug‐eluting balloon treatment of drug‐eluting in‐stent restenosis: First case report

A 55‐year‐old male underwent paclitaxel‐eluting stent implantation in a bifurcation lesion of his left anterior descending artery (LAD) during an episode of unstable angina in 2008. A late in‐stent restenosis developed 15 months after implantation of the drug‐eluting stent (DES) and was treated with paclitaxel eluting balloon. Two months later, during angiography for functional assessment of the significance of lesions in the circumflex artery, an aneurysm at the place of drug‐eluting balloon (DEB) inflation was observed. The patient was left on double antiplatelet therapy and scheduled for clinical observation after 3 months and control coronary angiography after 6 months for aneurysm progression follow‐up. © 2012 Wiley Periodicals, Inc.     

Comparison of rotational atherectomy and modified balloons prior to drug-eluting stent implantation for the treatment of heavily calcified coronary lesions

The optimal strategy for lesion preparation in heavily calcified coronary lesions (HCCL) prior to drug-eluting stent (DES) implantation remains debatable. This study sought to compare the performance of rotational atherectomy (RA) and modified balloon (MB)-based strategy in patients with HCCL receiving current-generation DES.This retrospective study comprised 564 consecutive patients who underwent RA (n = 229) or MB (n = 335) for HCCL at our hospital and were treated with DES. Baseline clinical and angiographic data was obtained from our database. Patients were clinically monitored for the occurrence of any adverse events during the hospitalization. One-year follow-up was conducted by either telephone contact or outpatient visits. 1:1 propensity score matching (PSM) was performed to balance the baseline covariates. After PSM, the clinical outcomes between the 2 groups were compared.After PSM, except more target lesion in right coronary artery existing in the RA group (P = .008), no significant statistical differences were shown in regard of the other angiographic and procedural characteristics of the 2 groups. Strategy success rates were all 100% in both groups. In the unadjusted Cox proportional hazard analysis, participants with RA had a significantly lower risk of target lesion revascularization (TLR) (hazard ratio, HR 0.275, 95% confidence intervals, CI 0.119–0.635, P = .003) and major adverse cardiac event (MACE) (HR 0.488, 95% 0.277–0.859, P = .013). After adjusting for potential confounding variables, RA was significantly associated with TLR (HR 0.32, 95% 0.12–0.853, P = .023), but no longer significantly associated with MACE (HR 0.674, 95% 0.329–1.381, P = .282).In patients with HCCL, lesion preparation with RA was safe and could improve strategy success rate. There was lower rate of TLR with RA, however, no significant difference was found in the MACE rate at 1-year follow-up between RA and MB-based strategy.     

Long‐term clinical outcomes after drug‐eluting stent implantation in unprotected left main coronary artery disease

Objective: To investigate long‐term outcomes of unprotected left main coronary artery (ULMCA) disease treatment using drug‐eluting stents (DES). Background: In several studies, DES implantation in ULMCA appeared safe and effective at mid‐term; however, to date, there is limited long‐term data. Methods : All consecutive patients undergoing sirolimus‐ or paclitaxel‐eluting stent implantation in ULMCA disease at a single institution were evaluated. The primary endpoint was long‐term major adverse cardiac events (MACE) defined as cardiac death, nonfatal myocardial infarction, or target lesion revascularization (TLR). Stent thrombosis (ST), according to Academic Research Consortium definitions, was also evaluated. Results: A total of 210 patients were assessed. In‐hospital MACE rate was 1%. During a mean follow‐up of 28.0 ± 14.5 months, MACE occurred in 26 patients (12.5%): cardiac death in nine patients (4.3%) and TLR in 17 patients (8.2%). The cumulative MACE‐free survival rate was 89.0, 87.4, and 85.4% at 1, 2, and 3 years, respectively. ST occurred in three patients (1.4%): one case was definite and the other two were probable/possible ST; there were no cases of very late ST. Binary restenosis occurred in 8.3%. The EuroScore >6 was the only independent predictor of MACE [hazard ratio (HR) 2.24, 95% confidence interval (CI) 1.05–4.77, P = 0.04]. There was a trend toward an increased risk of MACE associated with distal ULMCA location (HR 2.14, 95% CI 0.87–5.29, P = 0.10). Conclusions: Our study showed DES implantation in ULMCA to be feasible, safe, and effective at long term. Randomized trials comparing percutaneous versus surgical revascularization are warranted to define the treatment of choice for ULMCA disease. © 2009 Wiley‐Liss, Inc.